The acquired portfolio consists of 13 ANDAs already approved by the Food and Drug Administration and one pending approval.

PDS Biotechnology (NASDAQ:PDSB) said on Thursday it received U.S. FDA clearance for its Investigational New Drug application ...

The investment of over $6 million will expand LGM Pharma’s Rosenberg, Texas manufacturing facility as part of its Phase I ...

One of the most highly anticipated FDA decisions this month is for Alnylam Pharmaceuticals, which is seeking to expand the ...

The FDA has set a PDUFA target action date of October 23, 2025, for the low-dose atropine formulation.

Phase 1/2 trial evaluating the proprietary combination to be run under CRADA with the National Cancer InstituteSecondVersamune®platform candidate ...

To be a person in the year 2025 is to encounter, in one way or another, the marketing onslaught for compounded ...

President and CEO Ned McCoy shared with Becker's some of the company's key objectives for the year, including the launch of some of the first medications from its Petersburg, Va.-based plant, the ...

Ivor Elrifi, CEO of Tiziana Life Sciences, expressed enthusiasm about this milestone, stating, "We are excited to initiate this important clinical study with the support of the ALS Association grant.

Specialty pharmaceutical company PharmaTher Holdings’ drug application for Ketamine has received a June 4 approval goal date, advancing approval of the drug in the U.S. PharmaTher said it is ...

The FDA accepted a new drug application for SYD-101 to slow the progression of pediatric myopia and assigned a Prescription ...